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FDA 510(k)

BracePaste Fluoride Sealant

K-Number: K242537 · 2024-08-27

ApplicantAmerican Orthodontics Corp.
Decision Date2024-08-27
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BracePaste Fluoride Sealant is a medical device manufactured by American Orthodontics Corp.. It received FDA 510(k) clearance on 2024-08-27 under approval number K242537. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BracePaste Fluoride Sealant?

BracePaste Fluoride Sealant is a medical device that received FDA 510(k) clearance on 2024-08-27. It is manufactured by American Orthodontics Corp.. The 510(k) number is K242537.

When was BracePaste Fluoride Sealant approved by the FDA?

BracePaste Fluoride Sealant received FDA 510(k) clearance on 2024-08-27, under approval number K242537.

What company makes BracePaste Fluoride Sealant?

BracePaste Fluoride Sealant is manufactured by American Orthodontics Corp..

What is the FDA product code for BracePaste Fluoride Sealant?

The FDA product code for BracePaste Fluoride Sealant is DYH.

Related Devices (Code: DYH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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